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Innovative Health Sciences Receives Global Certification for Insignis™ Infusion System

Innovative Health Sciences (IHS) has reached a significant milestone by obtaining the Medical Device Regulations Quality Management System Certificate from BSI (CE MDR QMS), allowing for the worldwide introduction of their innovative Insignis™ Infusion System. This achievement comes after successfully navigating a two-stage audit for the European Medical Device Regulation (MDR), confirming the Insignis System’s robustness and safety in managing intravenous and subcutaneous medication delivery.

Meeting a Critical Need in Infusion Therapy

The Insignis™ Infusion System is particularly designed to tackle the unmet demand for a cost-effective and portable mechanical syringe infusion device. This device is vital for accurately administering medications, and its entry into the global market is timely, given the increasing need for reliable healthcare solutions in various settings, including military applications and for aging populations battling chronic diseases.

The rigorous audits conducted by BSI demanded strict compliance with MDR standards throughout the device's entire lifecycle, including its conception, design, manufacturing, and post-market surveillance. This certification not only solidifies IHS’s position in the EU but also models a pathway for markets beyond Europe where similar standards are recognized.

A Testament to Team Collaboration

The success of this rigorous audit marks a seminal moment for IHS, spearheaded by Regulatory Affairs Director Sheppard Bently and Lead Quality Engineer Tejasree Yenigalla, alongside several team members whose hard work bolstered the company’s efforts. Such teamwork underscores IHS's commitment to healthcare innovation and excellence. Andy Sealfon, the CEO of IHS, stated, “This accomplishment propels our company into global markets with a groundbreaking and highly versatile system.”

The Insignis Infusion System: Features and Applications

The Insignis Syringe Infusion System is a lightweight, non-electric device designed for delivering medication through both intravenous and subcutaneous routes. Its development is based on over 40 years of experience in medication delivery, prioritizing patient comfort with reduced pain and downtime associated with infusion treatments.

This device is instrumental for patients requiring subcutaneous immunoglobulin therapies, along with medications for various health complications, including neuromodulation. IHS is actively looking into expanding its device applications, potentially incorporating antibiotics and cardiac support medications into its offering.

As innovation in infusion solutions continues, the Insignis Infusion System stands ready to redefine the treatment landscape, offering improved access and outcomes for patients. IHS is poised to not only lead in technology innovation but also significantly enhance the quality of care available in diverse medical contexts worldwide.

Looking Towards the Future

With its global certification achieved, Innovative Health Sciences is transitioning to subsequent phases aimed at marketing and distribution. This will enable the company to target unserved patient populations with effective, accessible infusion solutions. The Insignis System exemplifies a future where healthcare devices can make a meaningful impact, ensuring that life-saving medications are available to those who need them most.

In a world that's increasingly aware of the importance of immediate, effective medical solutions, IHS's groundbreaking work represents not just a corporate success but a potential life-changing advancement for countless patients around the globe.